Active Surveillance Program for Misuse, Abuse, Addiction, Overdose and Death Attributed to EMBEDA® and Other Oral Extended-Release Morphine

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/36415
• EU PAS number:
  EUPAS13456
• Study ID:
  36415
• Official title and acronym:
  Active Surveillance Program for Misuse, Abuse, Addiction, Overdose and Death Attributed to EMBEDA® and Other Oral Extended-Release Morphine
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  To quantify the extent of misuse, abuse, addiction, overdose and death believed to be associated with each of two comparisons groups - Embeda and other oral ER morphine tablets and capsules - in the community over time NOTE: THIS STUDY WAS TERMINATED PREMATURELY BECAUSE THE SPONSOR WITHDREW THE NDA FOR EMBEDA
• Study status:
  Finalised

Research institutions and networks

Institutions

Rocky Mountain Poison & Drug Safety (RMPDS)

Study timelines

Date when funding contract was signed

Planned: 13/04/2015

Actual: 13/04/2015

Study start date

Planned: 30/09/2016

Actual: 30/09/2016

Date of final study report

Planned: 30/04/2020

Actual: 30/04/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

B4541022 Embeda PMR Protocol 14May2015 - GDMS

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only